Class II · Moderate risk Ongoing
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories…
Reason Lack of Assurance of Sterility: Leaking vials
Is Zoledronic recalled?
7 FDA recalls mention Zoledronic. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Zoledronic.
Class III · Low risk Terminated
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose…
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Class III · Low risk Terminated
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited…
Reason Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class III · Low risk Terminated
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India…
Reason Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class II · Moderate risk Terminated
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally…
Reason Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Class II · Moderate risk Terminated
Zoledronic Acid active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For…
Reason Lack of Assurance of Sterility; leaking of premix bags
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